Senior Design Quality Engineer

Job Description:

TransMedics, Inc., headquartered in Andover, MA, is revolutionizing organ care. With the goal of bringing new life to organ transplant, the pioneering Organ Care System (OCS™) was developed to address the major limitations of the current standard of care, cold storage. The OCS System serves as a portable, miniature intensive care unit that helps preserve donor organs in a near-physiologic state during transport. Unlike traditional cold-storage methods, the OCS System features ex-vivo, warm perfusion, and provides the means to monitor organ health, so that transplant patients can experience better outcomes. The only multi-organ platform, with the largest body of clinical evidence, the OCS System is designed to increase utilization and transplant volumes so that more transplantable organs can be made available worldwide. The Organ Care System is nothing less than a paradigm shift that can help transform organ preservation and optimization so that more patients can benefit from life-saving transplant procedures.

The Senior Design Quality Engineer to join our team in Andover, MA. The Senior Design Quality Engineer role plays a critical role in ensuring medical devices meet safety, effectiveness, regulatory compliance, and business requirements throughout the design and development process. Reporting into the Quality Department, the Senior Design Quality Engineer will collaborate with cross-functional teams supporting New Product Development and Sustaining Engineering projects for complex electromechanical medical devices, with a key focus on Software (embedded and standalone). The Senior Design Quality Engineer will provide input to the project teams for project decisions and development activities, ensuring the execution of design control and risk management activities in accordance with internal procedures and applicable standards/regulations.

RESPONSIBILITIES

• This position is responsible for, but not limited to, the following:
• Ensure design controls process for the projects meets applicable regulatory, corporate, and customer QMS requirements
• Collaborate with cross-functional teams including engineering, manufacturing, project managers, and regulatory
• Support new product development and sustaining projects for complex electrical/mechanical systems with software and disposables, with a key focus on Software in a medical device and embedded Software
• Provide quality input to product user needs, requirements, and specifications
• Provide quality input to critical to quality specifications
• Support development of engineering design documentation
• Support design and process verification and validations activities such as protocols, test cases, reports and resolution of issues identified during testing
• Support design reviews and development of the design history file
• Drive overall risk management process, including System Risk Analyses, FMEAs, risk controls and verification of effectiveness
• Provide quality input for Cybersecurity and Software Safety assessments
• Support Design Transfer activities
• Assist in preparation for regulatory submissions and provide support during audits and inspections
• Apply sound, systemic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Provide quality input and evaluation for Test Method Validations and Software Tool Validations
• Provide support during Corrective and Preventive Action (CAPA) activities and manage CAPAs when necessary
• Drive enhancements and continuous improvements to Standard Operating Procedures (SOPs)
• Improve knowledge of design controls, risk management, testing, statistics, and design verification / validation
• Mentor and provide guidance to junior engineers
• Perform other Quality Systems related duties as required
• Perform other TransMedics tasks and duties as assigned/required.

REQUIREMENTS:

• Bachelor’s degree in Engineering or other scientific or related field
• 8+ years experience in medical device or relevant regulated industry
• Strong knowledge of design control, risk management, and regulatory requirements (FDA, EU MDR, ISO 13485, ISO 14971)
• Working knowledge of design development and application of risk management
• Medical device software development and/or testing experience with compliance to 62304 and FDA guidelines
• Ability to organize and prioritize workflow across multiple projects
• Excellent organizational and interpersonal skills working in a cross-functional team
• Excel in an environment that embraces teamwork, change, risk-based decision-making and flexibility

TransMedics is committed to equitable and transparent compensation. The expected base salary range for this role is $93,300 - $132,900 which represents the company’s current good-faith estimate of compensation for this position. Actual salary will depend on factors such as, but not limited to, candidate experience, qualifications, skills, and the specific work location. This role may also be eligible for bonuses, equity, and a comprehensive benefits package (medical, dental, vision, retirement savings, paid time off, and wellness resources). We comply with all U.S. pay transparency laws and do not request or consider salary history.

EQUAL EMPLOYMENT OPPORTUNITY

TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability, protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.

Employee Benefit:

Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA Dental Vision Healthcare Flexible Spending Account Dependent Care Flexible Spending Account Short Term Disability Long Term Disability 401K Plan Pet insurance Employee Stock Purchase Plan

TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.